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Administrative data

Description of key information

Weight of evidence: No acute oral toxicity is expected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Quality of whole database:
Acceptable and well documented publication, similar to guideline or guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The reaction product was not tested. The acute oral toxicity is discussed with studies obtained with the different constituents.

Sucrose Stearate:

A subchronic study with the test item (CAS 37318 -31 -3) is available. No adverse effects related to the test substance were observed in this study. The study demonstrated that the test item was not toxic in Fischer rats. The NOAEL was determined to be 3240 mg/kg bw/day. Based on this result the LD50 was determined to be >3240 mg/kg bw/day. (see study)

Fatty Acids, C16 -18, Methyl Ester:

An acute oral toxicity study was performed with methyl stearate (CAS No. 112-61-8) according to OECD Guideline 401. Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl stearate /kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed and no abnormalities during gross necropsy were seen. The acute oral LD50 for methyl stearate in rats was found to greater than 2000 mg/kg bw. (see study)

Fatty Acids, C16-18 Methyl Ester and the test substances belong to the short chain methyl esters category (SCAE Me). A detailed justification for the grouping and read-across is provided in the Justification document (see Section 13).

Fatty Acids, C16 -18:

The available data for fatty acids provide a clear picture of low acute toxicity for this class of chemicals. All oral LD50 values were greater than 2,000 mg/kg, with little mortality being observed even at the highest doses tested in the studies (Clayton & Clayton, 1982; CIR, 1987).

 

CIR (1987) Final report of the safety assessment for oleic acid, lauric acid, palmitic acid, myristic acid, stearic acid. Prepared by the Expert Panel of the Cosmetic Ingredient Review, Washington D.C.

Clayton, G.D. and Clayton, F.E. (1982) Patty’s Industrial Hygiene and Toxicology. Volume 2C: Toxicology. 3rdRevised Edition. John Wiley & Sons: New York.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 1297/2014.